The following data is part of a premarket notification filed by Viasys Medsystems with the FDA for Anti-i.v. Enteral Feeding System.
Device ID | K043044 |
510k Number | K043044 |
Device Name: | ANTI-I.V. ENTERAL FEEDING SYSTEM |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
Contact | Stephanie Wasielewski |
Correspondent | Stephanie Wasielewski VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-04 |
Decision Date | 2005-05-06 |